salivary gland surgery before radiation therapy in preventing radiation-caused xerostomia in patients with head and neck cancer

Conditions: Head and Neck Cancer; Radiation Toxicity; Xerostomia

Summary: rationale: moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth). purpose: phase ii trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.

objectives: * determine the reproducibility of the surgical technique of submandibular salivary gland transfer in patients with head and neck cancer. * determine the rate and severity of radiation-induced xerostomia after this surgery in these patients. * determine the pattern of recurrence, disease-free survival, and overall survival of patients treated with this surgery followed by radiotherapy. * determine the quality of life of patients treated with this regimen. outline: this is a multicenter study. patients undergo surgical transfer of the submandibular salivary gland to the submental space. within 4-6 weeks after surgery, patients undergo radiotherapy once daily, 5 days a week for 5 ½ to 7 weeks in the absence of disease progression or unacceptable toxicity. salivary scans are performed before surgery, at 2-3 weeks after surgery, and then at 6 months from the start of radiotherapy. quality of life is assessed at baseline and at 3, 6, and 12 months from the start of radiotherapy. patients are followed every 3 months for 2 years and then every 6 months for 3 years and then annually. projected accrual: a total of 11-48 patients will be accrued for this study within 1.6 years.

Eligibility criteria:
disease characteristics: * one of the following diagnoses: * histologically confirmed, previously untreated squamous cell carcinoma of the oropharynx, hypopharynx, or larynx * head and neck cancer of unknown primary with unilateral metastases to the neck nodes * no n3 disease * no carcinoma of the oral cavity or nasopharynx * no bilateral neck node involvement * no suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer by ct scan or mri * no pre-epiglottic space involvement * no involvement of level 1 nodes on either side of the neck * no salivary gland malignancy * no recurrent disease patient characteristics: age * at least 18 years old performance status * zubrod 0-1 life expectancy * not specified hematopoietic * hemoglobin at least 10 g/dl hepatic * not specified renal * not specified other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no salivary gland disease (e.g., sjögren's syndrome) * no other malignancy within the past 3 years except basal cell or squamous cell skin cancer prior concurrent therapy: biologic therapy * not specified chemotherapy * more than 3 years since prior chemotherapy * no prior or concurrent neoadjuvant chemotherapy * concurrent adjuvant chemoradiotherapy (in addition to study radiotherapy) allowed endocrine therapy * not specified radiotherapy * see chemotherapy * no prior radiotherapy to the head and neck * no concurrent intensity-modulated radiotherapy surgery * not specified other * no concurrent cholinergic drugs * no concurrent anti-cholinergic drugs * no concurrent tricyclic drugs * no concurrent prophylactic amifostine or pilocarpine during and for at least 3 months after completion of study radiotherapy

Keywords: xerostomia radiation toxicity stage ii squamous cell carcinoma of the oropharynx stage iii squamous cell carcinoma of the oropharynx stage i squamous cell carcinoma of the hypopharynx stage ii squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the larynx untreated metastatic squamous neck cancer with occult primary stage iv squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the oropharynx